BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BIS

    DI: 10884521548381 · Model: 186-0212-PH · Covidien LP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

    Basic Information

    Brand Name
    BIS
    Primary DI
    10884521548381
    Version / Model
    186-0212-PH
    Company Name
    Covidien LP
    Labeler DUNS
    058614483
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2018-09-19
    Public Version
    8
    Public Version Date
    2024-02-23
    Public Version Status
    Update
    Public Device Record Key
    e23aafd3-4958-47e6-94fc-cbf2beed7ec0

    Device Description

    PHILIPS BILATERAL SENSOR KIT

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GXY Electrode, Cutaneous

    GMDN Terms

    Code Name
    46620 Cerebral oximeter sensor, single-use

    Identifiers

    Type ID
    Package 90884521548387
    Primary 10884521548381
    Unit of Use 30884521657865

    Customer Contacts

    Phone
    +1(508)261-8000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K143506 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    50 – 85 Degrees Fahrenheit